FDA.reportPublic FDA data

NDC 76329-8261-01 - Lorazepam

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
76329-8261
Requested NDC
76329-8261-01
Package NDCs from labels
76329-8261-1, 76329-8261-01
Manufacturer
REMEDYREPACK INC.
Effective date
2024-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-14HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - International Medication Systems, LimitedInternational Medication Systems, Limited2024-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-8261-1Lorazepam10 mL in 1 VIALINJECTION1013
76329-8261-1Lorazepam10 in 1 CARTONINJECTION1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-8261LORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]13Current NDC, Legacy NDC, 2 package rows20240306_7dda070d-7809-46c4-8592-eb4e4c509707.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-8261-1ML - Milliliter76329-8261434a2601-7460-488b-b472-386a13aa934312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LorazepamACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
LorazepamACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: B697894SGQ
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: B697894SGQ
LorazepamLORAZEPAMLeading Pharma, LLC5ca13415-4b77-4131-a9d2-6db26bc491672023-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAsclemed USA, Inc.91da80c8-3162-43f0-b53e-897070b26a542023-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
CVS Maximum Strength LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDECVS Pharmacy Inc.e6aff579-affb-41bb-8e36-53ea484cb0c52023-11-26WarningsExact identifier
unii: LKG8494WBH
LORAZEPAMLORAZEPAMAphena Pharma Solutions - Tennessee, LLC247110f2-5468-4593-8d86-41f8c869e03d2023-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: B697894SGQ
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: B697894SGQ
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: LKG8494WBH
LorazepamLORAZEPAMChartwell RX, LLCe075c78d-f0c6-4380-b769-bb8833d23ba52023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: LKG8494WBH
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: B697894SGQ
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: LKG8494WBH
LORAZEPAMLORAZEPAMA-S Medication Solutions823b1d71-a510-4d34-8015-60b55af23d782023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAmneal Pharmaceuticals LLCbf265c2e-ab2f-42e5-96cf-3998eb5a644d2023-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMSUN PHARMACEUTICAL INDUSTRIES INC0c1caa9c-9ef1-459c-86c3-adb939130a9f2023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMProficient Rx LPa407d3fe-ff0f-45b0-8a1e-c7a2a11c55692023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC8df3eed3-c936-4772-ab08-574c54dd8bf52023-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMPharmaceutical Associates, Inc.711b60a3-028d-41d4-aa17-8f976e6df23e2022-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMProficient Rx LP73bf2b31-5c7e-4b3a-9e97-8304931510b02022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.